Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems

NCT00715884 | Unknown Results DMC

• 1 other identifier: P07-6330
• Study Type: interventional
• Target: 678
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to show similar (non-inferior) safety and effectiveness between CYPHER® ELITE™ and CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems in a prospective, multi-center, randomized clinical study for the treatment of de novo native coronary lesions.

Conditions

Coronary Artery Disease; Coronary Atherosclerosis

Keywords

Atherosclerosis; de novo native coronary lesion

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Experienced Target Lesion Failure (TLF)

  The primary endpoint for this study is the percentage of participants who experienced Target Lesion Failure (TLF) during the 12 months post-procedure. A TLF event is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.

  12-months post-procedure

Secondary Outcomes (18)

• Percentage of Lesion Success

  At procedure

• Percentage of Device Success - Protocol Definition

  At procedure

• Percentage of Device Success - All CYPHER® Stents Included

  At procedure

• Percentage of Participants Who Achieved Procedure Success

  At procedure during hospital stay

• Percentage of Participants Who Experienced Target Lesion Revascularization (TLR)

  12 months post-procedure

Study Arms (2)

1

EXPERIMENTAL

CYPHER® ELITE™ Sirolimus-Eluting Stent System.

Device: CYPHER® ELITE™ Sirolimus-Eluting Stent System

2

ACTIVE COMPARATOR

CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System

Device: CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System

Interventions

CYPHER® ELITE™ Sirolimus-Eluting Stent System DEVICE

Drug eluting stent

Also known as: Cypher ELITE

1

CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System DEVICE

Drug eluting stent

Also known as: CYPHER Bx VELOCITY

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with de novo atherosclerotic CAD in 1 or 2 vessels;
• The subject must be \>/= 18 years of age;
• Female of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment;
• Diagnosis of angina pectoris as defined by stable angina pectoris Canadian Cardiovascular Society Classification (Class I, II, III) OR non-ST segment elevation acute coronary syndrome (Braunwald Classification B\&C) OR non-ST segment elevation myocardial infarction \>/= 48 hours from the time of study index procedure OR asymptomatic subjects with a positive stress test;
• Treatment of \</= two lesions in one or two major coronary arteries (1 target lesion in each of 2 vessels or 2 target lesions in 1 vessel);
• Target vessel diameter must be \>/= 2.25mm and \</= 4.0 in diameter (visual estimate);
• Target lesion stenosis is \> 50% and \< 100% (visual estimate);
• Target lesion length \<30mm (for each target lesion(s)) with a total implanted stent length \< 66mm. Additional stents can be used to treat dissections, etc,: however, these must be the same stent to which the subject has been randomized in the study.
• Subject or Legally Authorized Representative must provide written informed consent prior to the procedure using a form that is approved by the Institutional Review Board/Independent Ethics Committee.

You may not qualify if:

• ST Segment Elevation Myocardial Infarction (STEMI) within 30 days of the study index procedure;
• Unprotected left main coronary disease with \>/= 50% stenosis;
• Total coronary occlusion or TIMI grade 0 or 1 in the target vessel;
• Angiographic evidence of thrombus within target lesion(s);
• Calcified target lesion(s) which cannot be, in the investigator's opinion, successfully pre-dilated;
• Bifurcation disease involving a side branch \>/= 2 mm in diameter;
• Prior stent within 5 mm of target lesion(s);
• Ostial target lesion(s);
• Target lesion(s) within a coronary bypass graft (e.g., saphenous vein or arterial graft);
• Documented left ventricular ejection fraction \</= 25%;
• Impaired renal function (creatinine \> 250 μmol/L or \> 2.5 mg/dl) at the time of treatment;
• Pretreatment with devices other than conventional balloon angioplasty;
• Significant angulation in the target vessel that, in the Investigator's opinion, may preclude stent delivery and deployment;
• Subject previously treated with brachytherapy;
• Recipient of heart transplant;

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

The study was terminated early by the Sponsor for business reasons. Hence the data was under powered for hypothesis testing. No definitive conclusions can be made from this data.

Results Point of Contact

• Title: Amy Orlick, Associate Director Clinical Research
• Organization: Cordis

AOrlick@its.jnj.com

908-541-4347

Study Officials

• Lowell Satler, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 15, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: September 1, 2014
• Last Updated: January 20, 2014
• Results First Posted: May 6, 2011

Record last verified: 2013-12

Locations

US (1)